Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter

Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is an FDA 510(k)-cleared medical device (K162675) manufactured by Masimo Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 27, 2016. Regulation: 8.